Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

Venous Thromboembolism Clinical Trial

Official title:

Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02707263
• Other study ID #: 15-01051
• Status: Withdrawn
• Phase: N/A
• First received: March 1, 2016
• Last updated: April 25, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to the medical ICU (MICU)

• High-risk for Venous Thromboembolism (VTE) = 1 of the following:

• Body Mass Index (BMI) = 30 kg/m2

• Personal or family history of VTE

• Receiving vasopressors

Exclusion Criteria:

• Indication for therapeutic anticoagulation

• Evidence of deep vein thrombosis (DVT) on ultrasonography at admission

• Indwelling intrathecal, epidural, or other indwelling deep catheters

• Recent (< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13

• Recent (< 3 months) major trauma

• Recent (< 3 months) neurosurgery or orthopedic surgery Pregnancy

• Contraindication to heparin or heparin products

Related Conditions & MeSH terms

• Critical Illness
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• intravenous continuous infusion of heparin (IV UFH)

• Subcutaneous Heparin

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Coagulation (Anti-Xa levels) in patients receiving Intravenous Continuous Infusion Heparin versus subcutaneous Heparin		3 Days